Method of locating the tip of a central venous catheter

ABSTRACT

A method of locating a tip of a central venous catheter (“CVC”) having a distal and proximal pair of electrodes disposed within the superior vena cava, right atrium, and/or right ventricle. The method includes obtaining a distal and proximal electrical signal from the distal and proximal pair of electrodes and using those signals to generate a distal and proximal P wave, respectively. A deflection value is determined for each of the P waves. A ratio of the deflection values is then used to determine a location of the tip of the CVC. Optionally, the CVC may include a reference pair of electrodes disposed within the superior vena cava from which a reference deflection value may be obtained. A ratio of one of the other deflection values to the reference deflection value may be used to determine the location of the tip of the CVC.

PRIORITY

This application is a division of U.S. patent application Ser. No.13/969,265, filed Aug. 16, 2013, now U.S. Pat. No. 8,858,455, which is adivision of U.S. patent application Ser. No. 12/878,915, filed Sep. 9,2010, now U.S. Pat. No. 8,512,256, which is a division of U.S. patentapplication Ser. No. 11/552,094, filed Oct. 23, 2006, now U.S. Pat. No.7,794,407, each of which is incorporated by reference into thisapplication as if fully set forth herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention is directed generally to devices for and methodsof locating a catheter inside a body and more particularly to devicesfor and methods of locating the tip of a central venous catheter insidethe superior vena cava, right atrium, and/or right ventricle usinginformation obtained from an electrocardiogram.

2. Description of the Related Art

Central venous catheters (“CVC”) include any catheter designed toutilize the central veins (e.g., subclavian and superior vena cava) orright sided cardiac chambers for the delivery and/or withdrawal ofblood, blood products, therapeutic agents, and/or diagnostic agents.CVCs also include catheters inserted into the central veins or rightsided cardiac chambers for the acquisition of hemodynamic data. Standardcentral venous catheters for intravenous access, dialysis catheters,percutaneously introduced central catheters (“PICC” lines), and rightheart (“Swan-Ganz™”) catheters are examples of CVCs.

The standard of care for placing a CVC dictates that the tip of the CVClie just above and not inside the right atrium. In fact, in 1989, theFood and Drug Administration issued a warning citing an increased riskof perforation of the right atrium, clot formation, and arrhythmiasamong other potential complications resulting from the tip of the CVCbeing placed inside the right atrium.

While CVCs have been used for many years, determining the position ofthe tip of the CVC has always been problematic. Currently, a chest x-rayis used to determine the position of the tip of the CVC. Because CVC maybe a radiopaque and/or include radiopaque materials, the CVC is visibleon an x-ray. However, this method has several drawbacks. For example,obtaining a chest x-ray is labor intensive and expensive. In recentyears, CVCs, which were traditionally placed in a hospital in-patientsetting, are being placed in an outpatient setting more frequently. Inan outpatient setting, obtaining a chest x-ray to determine the positionof the tip of the CVC can be very cumbersome and may not be obtained ina timely manner. Therefore, using a chest x-ray to determine theposition of the tip of the CVC may introduce a considerable delay,prolonging the procedure. Generally, the operator will leave the patientto perform other duties while the x-ray is processed. If the tip isimproperly placed, the operator must return to the patient's bedside toreposition the CVC. To reposition the CVC, the operator must open thesterile dressing, cut the sutures, re-suture, and redress the wound, allof which potentially expose the patient to discomfort and infection.

In addition to the need to know where the tip is during initialplacement, the CVC may migrate or otherwise move after the initialplacement and require re-positioning. Therefore, the operator mustmonitor or periodically reevaluate the location of the tip.

An electrocardiogram (ECG) measures electrical potential changesoccurring in the heart. Referring to FIGS. 1A-1C, the ECG measurementsmay be visualized or displayed as an ECG trace, which includes ECGwaveforms. The P wave portion of the ECG waveforms represents atrialmuscle depolarization: the first half is attributable to the rightatrium and the second half to the left atrium. Under normalcircumstances, atrial muscle depolarization is initiated by a release ofan excitatory signal from the sino-atrial node, a specialized strip oftissue located at the juncture of the superior vena cava (“SVC”) andright atrium.

Techniques of using ECG waveforms to locate the tip of a CVC have beenavailable since the 1940s. Some of these prior art devices construct anintravascular ECG trace by placing an electrode near the tip of the CVCand using that electrode to measure the voltage near the tip of the CVCrelative to a surface electrode(s) and/or a second electrode spaced fromthe first.

These techniques have shown that both the magnitude and shape of the Pwave change depending upon the positioning or location of the electrodeattached to the tip of the CVC. Referring to FIGS. 1A and 1B, twoexemplary ECG traces are provided for illustrative purposes.

FIG. 1A is an ECG trace made when the electrode attached to tip of theCVC is in the SVC. This tip location corresponds to position “1”depicted in FIG. 2A. The portion of the ECG trace corresponding to anexemplary P wave produced when the electrode attached to the tip islocated in position “1” is labeled “P1.”

FIG. 1B is an ECG trace made when the electrode attached to the tip ofthe CVC is approaching the sino-atrial node and stops at a locationadjacent to the sino-atrial node. These tip locations correspond tomoving the tip from a position “2” to position “3” depicted in FIG. 2A.The portion of the ECG trace corresponding to an exemplary P waveproduced when the electrode attached to the tip is approaching thesino-atrial node is labeled “P2” and the portion of the ECG tracecorresponding to an exemplary P wave produced when the electrodeattached to the tip is located adjacent to the sino-atrial node islabeled “P3.”

Normally as the electrode attached to the tip of the CVC moves from theSVC (position “1”) toward the sino-atrial node (position “3”), themaximum value of the absolute value of the voltage of the P waveincreases dramatically. When the electrode attached to tip of the CVC isadjacent to the sino-atrial node (position “3”), the voltage of the Pwave (please see “P3” of FIG. 1B) reaches a maximum value that is morethan twice the value experienced in the SVC and may be as large as eighttimes the voltage in the SVC. When this occurs, the tip of the CVC isconsidered to have entered into the right atrium. Because the magnitudeof the P wave more than doubles when the electrode attached to tip ofthe CVC is adjacent to the sino-atrial node, this information may beused to place the tip of the CVC within 1-2 cm proximal to thesino-atrial node. Additionally, as the electrode attached to tip of theCVC moves from the SVC toward the right atrium, the shape of the P wavechanges from a “u” shape (FIG. 1A) to a spike-like shape (FIG. 1B).

Referring to FIG. 2B, another exemplary illustration of the P waveportion of the ECG trace produced when the electrode attached to the tipof the CVC is located at positions 1-5 depicted in FIG. 2A is provided.The P wave portions of the ECG traces of FIG. 2B are labeled with theletter “P” and occur between the vertical dashed lines. Each of theexemplary traces is numbered to correspond to positions “1” through “5.”Therefore, the ECG trace “1” was produced when the electrode attached tothe tip was located in the SVC. The trace “2” was produced when theelectrode attached to the tip was in position “2.” And, the trace “3”was produced when the electrode attached to the tip was adjacent to thesino-atrial node.

As the electrode attached to tip of the CVC is advanced further into theright atrium, the polarity of the P wave “P” changes from predominantlynegative near the top of the right atrium (position “3”) to isoelectric(i.e., half has a positive polarity and half has a negative polarity)near the middle of the right atrium (position “4”) to almost entirelypositive at the bottom of the right atrium (position “5”). These changesin the P wave “P” are illustrated in traces “3” through “5.”

FIG. 1C is an ECG trace made when the electrode attached to tip of theCVC is in the right ventricle. The portion of the ECG tracecorresponding to an exemplary P wave produced when the electrodeattached to the tip is labeled “P6.” When the electrode attached to tipof the CVC is advanced into the right ventricle, the maximum magnitudeof the absolute value of the P wave “P6” approximates the maximummagnitude of the absolute value of the P wave “P1” when the electrodeattached to tip of the CVC was inside the SVC above the sino-atrial node(i.e., located at position “1”). However, the polarity of the first halfof P wave “P6,” which corresponds to the right atrium, is opposite.

The first technique developed for viewing the ECG waveform during theinsertion of a CVC used a column of saline disposed within a hollow tubeor lumen longitudinally traversing the CVC. The column of salineprovides a conductive medium. Saline was inserted into the lumen by asaline filled syringe with a metal needle. The needle of the syringeremained within the entrance to the lumen or port in contact with thecolumn of saline after the lumen was filled. One end of a double-sidedalligator clip was attached to the needle and the other end was attachedto an ECG lead, which in turn was attached to an ECG monitor. By usingthe saline solution filled CVC as a unipolar electrode and a secondvirtual electrode generated by ECG software from three surfaceelectrodes, an intravascular ECG was obtained. The operator would adjustthe position of the tip of the CVC based on the magnitude and shape ofthe P wave displayed by the ECG monitor.

Subsequently, this technique was modified by substituting anArrow-Johans adapter for the metal needle. The Arrow-Johans adapter is astandard tubing connector with a embedded conductive ECG eyelet. TheArrow-Johans adapter may be placed in line with any conventional CVC. Ina closed system, the tubing and CVC may be filled with saline, i.e., aconductive medium, and the CVC used as a unipolar electrode inconjunction with surface electrodes and a standard ECG monitor. The ECGeyelet is placed in contact with the saline in the lumen of the CVC. Oneend of the ECG lead is attached to the ECG eyelet and the other end tothe ECG monitor for displaying the intravascular ECG waveforms. Becausethe system must be closed to prevent the saline from leaking out, thissystem works best after the guide wire used to thread the CVC forwardhas been withdrawn, i.e., after placement has been completed. Therefore,although the catheter may be withdrawn after initial placement, it maynot be advanced into proper position.

B. Braun introduced its Certofix catheter to be used in conjunction withits CERTODYNE adapter. In this system, a patch lead with two ends has analligator clip connected to one end. The alligator clip is clipped tothe CVC guide wire. The other end of the patch lead includes a connectorthat is plugged into the CERTODYNE adapter. The ECG may be obtainedduring placement and the catheter may be advanced or withdrawn asdesired. However, the CERTODYNE adapter has many moving parts and is notsterile, making the procedure cumbersome to perform and the operativefield more congested. Additionally, the sterile field may becomecontaminated by the non-sterile equipment.

With respect to all of these prior art methods of using an ECG trace toplace the tip of the CVC, some degree of expertise is required tointerpret the P waves measured because the user must advance the guidewire slowly and watch for changes in the P wave. If the catheter isinserted too far too quickly and the changes to the P wave go unnoticed(i.e., the operator fails to notice the increase or spike in the voltageexperienced when the electrode attached to the tip is in the rightatrium), the operator may mistakenly believe the tip is in the SVC when,in fact, the tip is in the right ventricle. If this occurs, advancingthe tip may injure the patient.

U.S. Pat. Nos. 5,078,678 and 5,121,750 both issued to Katims teach amethod of using the P wave portion of an ECG trace to guide placement ofthe tip of the CVC. The CVC includes two empty lumens into which atransmission line is fed or an electrolyte is added. Each of the lumenshas a distal exit aperture located near the tip of the CVC. The two exitapertures are spaced from one another. In this manner, two spaced apartelectrodes or a single anode/cathode pair are constructed near the tipof the CVC. The voltage or potential of one of the electrodes relativeto the other varies depending upon the placement of the electrodes. Thevoltage of the electrodes is conducted to a catheter monitoring system.The catheter monitoring system detects increases and decreases in thevoltage of the P wave. The voltage increases as the electrodes approachthe sino-atrial node and decrease as the electrodes move away from thesino-atrial node. Based on whether the voltage is increasing ordecreasing, the operator is instructed by messages on a screen toadvance or withdraw the CVC.

While Katims teaches a method of locating the tip of a CVC relative tothe sino-atrial node, Katims relies on advancing or withdrawing the CVCand observing the changes of the P wave. Katims does not disclose amethod of determining the location of the tip of the CVC based on asingle stationary position. Unless the entire insertion procedure ismonitored carefully, the method cannot determine the position of the tipof the CVC. Further, the Katims method may be unsuitable for determiningthe location of a previously positioned stationary tip.

Other devices such as Bard's Zucker, Myler, Gorlin, and CVP/Pacing LumenElectrode Catheters are designed primarily to pace. These devicesinclude a pair of electrodes at their tip that are permanently installedand designed to contact the endocardial lining. These devices include alumen, which may be used to deliver and/or withdraw medications orfluids as well as for pressure monitoring. These leads are not designedfor tip location and do not include multi-lumen capability.

A method of obtaining an intravascular ECG for the purposes of placing atemporary pacing wire was described in U.S. Pat. No. 5,666,958 issued toRothenberg et. al. Rothenberg et. al discloses a bipolar pacing wirehaving a distal electrode. The distal electrode serves as a unipolarelectrode when the pacing wire is inserted into the chambers of theheart. The pacing wire is connected to a bedside monitor through aspecialized connector for the purposes of displaying the ECG waveformsdetected by the distal electrode.

Given the volume of CVCs placed yearly and the increasing demandparticularly for PICC lines (devices that permit the delivery ofintravenous therapeutic agents in the outpatient setting, avoiding theneed for hospitalization) a great need exists for methods and devicesrelated to locating the tip of a CVC. Particularly, devices and methodsare needed that are capable of determining the location of the tipbefore the operator leaves the bedside of the patient. Further, a methodof determining the location (SVC, right atrium, or right ventricle) ofthe tip from a single data point rather than from a series of datapoints collected as the catheter is moved may be advantageous. Such asystem may be helpful during initial placement and/or repositioning. Aneed also exists for a device for or a method of interpreting the ECGwaveforms that does not require specialized expertise. Methods anddevices that avoid the need for hospital and x-ray facilities are alsodesirable. A need also exists for devices and methods related todetermining the position of the tip of the CVC that are less expensive,expose patients to fewer risks, and/or are less cumbersome than thex-ray method currently in use.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

FIG. 1A is an exemplary ECG trace obtained from an electrode placedinside the SVC.

FIG. 1B is an exemplary ECG trace obtained from an electrode approachingthe sino-atrial node and stopping adjacent thereto.

FIG. 1C is an exemplary ECG trace obtained from an electrode placedinside the right ventricle.

FIG. 2A is an illustration of a partial cross-section of the heartproviding three exemplary tip locations 1, 2, 3, 4, and 5.

FIG. 2B is a series of exemplary P wave traces 1, 2, 3, 4, and 5obtained from an electrode placed in each of the exemplary tip locations1, 2, 3, 4, and 5 depicted in FIG. 2A, respectively.

FIG. 3 is a CVC constructed in accordance with aspects of the presentinvention.

FIG. 4 is an embodiment of a signal analysis system for use with the CVCof FIG. 3.

FIG. 5 is a block diagram illustrating the components of the signalanalysis system of FIG. 4.

DETAILED DESCRIPTION OF THE INVENTION

Aspects of the present invention are directed toward a device forlocating the tip of a CVC and a method of determining the location ofthe tip of a CVC. In the embodiment depicted in FIG. 3, the inventionincludes a CVC 100 constructed using any manner known in the art from aflexible nonconductive material, such as polyurethane or other suitablepolymer material. It may also be desirable to use a radiopaque material.As is appreciated by those of ordinary skill in the art, the materialused to construct the CVC 100 may include materials and/or coatings thatprovide improved anti-thrombotic or anti-bacterial properties. The CVC100 has a body 130 configured to be received within a central vein. Thebody 130 may include a distal end 110 having a tapered tip 112 and aproximal end 120 spaced longitudinally along the body 130 from thedistal end 110.

The body 130 may include one or more lumens 132 that traverse the lengthof the body and may have one or more openings 134 at or spaced from thetip 112. The openings 134 permit passage of material(s) between thelumen 132 and the environment outside the CVC 100. The lumens 132 may beused as conduits for the passage of materials such as medications and/orother fluids to and from the environment outside the CVC 100. Forexample, the lumen 132 may be used to aspirate blood into the CVC 100and/or provide a conduit through which pressure data may be collectedand used to construct pressure waveforms. The environment outside theCVC 100 may include the inside of the SVC, right atrium, and/or rightventricle. The CVC 100 is provided for illustrative purposes and thoseof ordinary skill in the art appreciate that alternate embodiments ofCVC 100 including embodiments with additional lumens, a flow directedballoon tip, thermistors, thermodilution ports, pacing wire ports,embedded pacing electrodes, and the like are within the scope of thepresent invention.

In one embodiment, the invention includes four longitudinally spacedapart electrodes 150, 152, 154, and 156. Each electrode 150, 152, 154,and 156 is in electrical communication with a wire 160, 162, 164, and166, respectively. In one embodiment, the electrodes 150, 152, 154, and156 are constructed from the distal end of each of the wires 160, 162,164, and 166. In another embodiment, the electrodes 150, 152, 154, and156 are attached to the ends of the wires 160, 162, 164, and 166 by anymethod known in the art for attaching an electrode to a wire, includingsoldering. The wires 160, 162, 164, and 166 are electrically isolatedfrom one another. The wires 160, 162, 164, and 166 may be insulated fromthe environment outside the body 130 by the body 130.

The electrodes 150, 152, 154, and 156 and the wires 160, 162, 164, and166 may be constructed from any suitable materials known in the art suchas stainless steel or platinum. The electrodes 150, 152, 154, and 156may be about 6 mm to about 12 mm long, about 6 mm to about 12 mm wide,and about 1 mm to about 4 mm thick. The wires 160, 162, 164, and 166 maybe constructed using any electrical lead wire suitable for obtaining anECG trace.

Optionally, the invention may include two longitudinally spaced apartelectrodes 157 and 158. Each of the electrodes 157 and 158 may beelectrical communication with a wire 167 and 168, respectively. Theelectrodes 157 and 158 and wires 167 and 168 may be constructed in amanner substantially similar to that used to construct the electrodes150, 152, 154, and 156 and the wires 160, 162, 164, and 166,respectively. In one embodiment, the electrode 157 and 158 arepositioned proximal to the electrodes 150, 152, 154, and 156.

Electrodes 150, 152, 154, and 156 may form two anode/cathode pairs. Forexample, electrodes 150 and 152 may form a first or proximalanode/cathode pair 180 and electrodes 154 and 156 may form a second ordistal anode/cathode pair 182. Optional electrodes 157 and 158 may forman optional third or reference anode/cathode pair 184. A pair ofelectrodes forming an anode/cathode pair may be attached to a pair ofinsulated wires housed within a single cable. In one embodiment, a pairof bipolar lead wires are used. In this manner, the four electrodes ofthe proximal and distal anode/cathode pairs 180 and 182 may be attachedto two lead wires. A third bipolar lead wire may be included for usewith the reference anode/cathode pair 184. Alternatively, the proximaland distal anode/cathode pairs 180 and 182 may be attached to fourinsulated wires housed within a single cable such a dual bipolar leadwire.

The wires 160, 162, 164, and 166 and electrodes 150, 152, 154, and 156may be permanently embedded into the body 130 of the CVC 100 orremovably inserted into one or more channels or lumens 132 formed in theCVC 100 for potential future removal and/or replacement. The wires 167and 168 and electrodes 157 and 158 may be incorporated into the CVC 100in any manner described with respect to wires 160, 162, 164, and 166 andelectrodes 150, 152, 154, and 156, respectively.

The electrodes 150, 152, 154, and 156 are in electrical communicationwith the environment outside the CVC 100. In one embodiment, a portionof each of the electrodes 150, 152, 154, and 156 are exposed to theenvironment outside the CVC 100 by apertures 170, 172, 174, and 176formed in the body 130 adjacent to the electrodes 150, 152, 154, and156, respectively. In embodiments including optional electrodes 157 and158, a portion of each of the electrodes 157 and 158 may be exposed tothe environment outside the CVC 100 by apertures 177 and 178 formed inthe body 130 adjacent to the electrodes 157 and 158, respectively. Theapertures 177 and 178 may be constructed in any manner suitable forconstructing apertures 170, 172, 174, and 176. The apertures 170, 172,174, and 176 may be formed in the body 130 by any method known in theart and the invention is not limited by the method used to construct theapertures 170, 172, 174, and 176. While the electrodes 150, 152, 154,and 156 depicted in the drawings extend outwardly from the body 130through the apertures 170, 172, 174, and 176, it is understood by thoseof ordinary skill in the art, that electrodes 150, 152, 154, and 156 mayreside at the bottom of the apertures 170, 172, 174, and 176 which mayprovide a passageway for fluids in the outside environment to theelectrodes 150, 152, 154, and 156. Alternatively, the portion of theelectrodes 150, 152, 154, and 156 in electrical communication with theenvironment outside the CVC 100 may be flush with the outside surface ofthe CVC 100.

The electrode 156 may be located at or spaced from the tip 112. In oneembodiment, the electrode 156 is less than about 5 mm from the tip 112.The spacing between an anode and cathode of the anode/cathode pairs 180and 182 may be about 1 mm to about 4 mm. In one embodiment, the spacingbetween an anode and cathode of the anode/cathode pairs 180 and 182 isabout 3 mm.

In one embodiment, the distance between the electrodes 154 and 152 isless than the height of the right atrium. In an adult, the height of theright atrium may be approximately equal to or greater than about 4 cm.In one exemplary embodiment, the distance between the electrode 154 and152 may be about 3 cm. In embodiments including optional electrodes 157and 158, the distance between the electrodes 150 and 158 may be about 10cm to about 18 cm.

Those of ordinary skill in the art appreciate that the size and spacingof the electrodes provided herein may require modification for use withpatients that are larger or smaller than a typical adult and suchembodiments are within the scope of the present invention. For example,smaller electrodes with a closer spacing may be required for use with apediatric patient.

Referring to FIG. 4, the CVC 100 may gain venous access to the SVC byany method known in the art including inserting the CVC 100 in astandard sterile fashion through the subclavian, one of the jugularveins, or a peripheral vein and directing the tip 112 of the CVC 100through that vein to the SVC.

Each of the anode/cathode pairs 180 and 182 may be used to generate anECG trace. In this manner, the ECG waveforms detected by the proximalpair 180 may be compared to the ECG waveform detected by the distal pair182. In one embodiment, the P wave portion of each trace is compared todetermine the position of the tip 112 of the CVC 100 within the SVC,right atrium, and right ventricle.

In embodiments including the reference anode/cathode pair 184, thereference anode/cathode pair 184 may be used to generate an ECG trace.Referring to FIG. 4, because the reference anode/cathode pairs 184 maybe located substantially proximally from the proximal and distalanode/cathode pairs 180 and 182, the reference anode/cathode pair 184may remain in the SVC after the proximal and distal anode/cathode pairs180 and 182 have entered the heart. In one embodiment, the spacingbetween the anode/cathode pair 184 and the proximal pair 180 is largeenough to insure the reference anode/cathode pair 184 remains inside theSVC when the distal anode/cathode pair 182 is inside the rightventricle. In this manner, the reference anode/cathode pair 184, may beused to detect the ECG waveform within the SVC while the catheter isbeing placed.

The ECG waveforms detected by the proximal anode/cathode pair 180 and/ordistal anode/cathode pair 182 may be compared to the ECG waveformdetected by the reference anode/cathode pair 184. In one embodiment, theP wave portion of the ECG trace detected by the proximal anode/cathodepair 180 and/or distal anode/cathode pair 182 is compared to P waveportion of the ECG trace detected by the reference anode/cathode pair184 to determine whether the tip 112 of the CVC 100 is located withinthe SVC, right atrium, or right ventricle.

The deflection of the trace, i.e., its vertical height relative to thebaseline may be used to compare the P waves of the proximal and distalanode/cathode pairs 180 and 182. The deflection of the trace may also beused to compare the P waves of the proximal anode/cathode pair 180and/or distal anode/cathode pair 182 to the reference anode/cathode pair184. Because a P wave constitutes a voltage change over time, thedeflection of the P wave is not constant. In one embodiment, the P waveis represented by an array or series of discrete numerical values.

The deflection value may be calculated in several ways. For example, themaximum or peak deflection may be used. Alternatively, the deflectionvalue may be calculated as the difference between the maximum deflectionand the minimum deflection. The deflection value may also be calculatedas the sum of the absolute value of the maximum and minimum deflections.If the P wave has two peaks, which may occur when one of theanode/cathode pairs 180 and 182 are located within the right atrium (seeposition 4 of FIGS. 2A and 2B), the deflection value may be calculatedby totaling the absolute value of the two peaks. When this method isused, the deflection value of the P wave measured at positions 3-5 mayall be approximately be equal. Further, if discrete data is being used,the discrete deflection quantities may be totaled. If continuous data isbeing used, the integral under the P wave may be used. Further, theaverage P wave deflection may be used. Because the polarity of portionsof the P wave change depending upon the location of the anode/cathodepairs 180 and 182, it may be beneficial to use the absolute value of thedeflection of the P wave to calculate the deflection value.

For the purposes of this application, the term “deflection value” willbe used hereafter to describe the metric used to compare the P wavesdetected by the proximal and distal anode/cathode pairs 180 and 182. Thedeflection value may also be used to compare the P wave detected by thereference anode/cathode pair 184 to the P wave detected by one or bothof the proximal and distal anode/cathode pairs 180 and 182. It isappreciated by those of ordinary skill in the art that the deflectionvalue may be determined in numerous ways including those listed aboveand others not listed and the invention is not limited by the method andmanner of determining the deflection value of the P wave.

In one exemplary embodiment, the deflection value is calculated as thesum of the absolute value of the maximum and minimum deflections whenthe maximum and minimum deflections have opposite polarities. Thedeflection value is calculated as the larger of the absolute value ofthe maximum and minimum deflections when the maximum and minimumdeflections have the same polarity. In other words, the vertical heightof the P wave is used. A first ratio of the deflection value of thedistal anode/cathode pair 182 to the deflection value of the proximalanode/cathode pair 180 may be calculated.

When both of the anode/cathode pairs 180 and 182 are within the SVC, thedeflection value of the P wave detected by each of them is substantiallyidentical and the first ratio of their P wave deflection values equalsapproximately one. The deflection value of one or both of the P wavesmay be stored or otherwise recorded.

The user or operator may wish to continue advancing the CVC until thesino-atrial node is detected. When an anode/cathode pair 180 or 182 isapproximately 1 cm to approximately 2 cm proximal to the sino-atrialnode and therefore, by inference, approximately 1 cm to approximately 2cm proximal to the entrance of the right atrium, the deflection value ofthe P wave detected by that anode/cathode pair may increase.

When the distal anode/cathode pair 182 enters the right atrium and theproximal anode/cathode pair 180 is still in the SVC, the deflectionvalue of the P wave detected by the distal anode/cathode pair 182 may beat least double the deflection value of the P wave detected by theproximal anode/cathode pair 180. Therefore, the first ratio of the Pwave deflection values of the distal anode/cathode pair 182 to theproximal anode/cathode pair 180 is greater than or equal to two. Whenthis happens, the user or operator should withdraw the CVC 100.

A predetermined maximum threshold value may be used to determine whetherthe user or operator should withdraw the CVC 100. If the first ratioexceeds the maximum threshold value, the CVC 100 should be withdrawn. Inone embodiment, the maximum threshold value may be approximately two.

When the distal anode/cathode pair 182 enters the right ventricle, theproximal anode/cathode pair 180 may be in the right atrium. Because thedeflection value of the P wave experienced in the right ventricle isapproximately equal to the deflection value of the P wave experienced inthe SVC, the first ratio of the P wave deflection values of the distalanode/cathode pair 182 to the proximal anode/cathode pair 180 is lessthan or equal to about one half. Therefore, when the ratio is less thanabout one half, the user or operator should withdraw the CVC 100.

A predetermined minimum threshold value may be used to determine whetherthe user or operator should withdraw the CVC 100. If the first ratio isless than the minimum threshold value, the CVC 100 should be withdrawn.In one embodiment, the minimum threshold value may be approximately onehalf.

The distal anode/cathode pair 182 and the proximal anode/cathode pair180 may be in the right atrium at the same time. When this occurs, thedeflection value of the P waves detected by each would be very similarif not identical making their first ratio approximately equal to one.Therefore, a second ratio may be calculated to determine the location ofthe tip 112 of the CVC 100. The second ratio may include the ratio ofthe deflection value of the P wave detected by the proximalanode/cathode pair 180 to the deflection value of the P wave detected inthe SVC. In one embodiment, the second ratio may include the ratio ofthe deflection value of the P wave detected by the proximalanode/cathode pair 180 to the deflection value of the P wave detected bythe reference anode/cathode pair 184. In embodiments that include areference anode/cathode pair 184, the reference anode/cathode pair 184may detect the P wave in the SVC. Because the proximal anode/cathodepair 180 is inside the right atrium the deflection value of its P waveis greater than or equal to twice the deflection value of the P waveobserved in the SVC. When the second ratio is equal to or greater thantwo, the user or operator should withdraw the CVC 100. The predeterminedmaximum threshold value may be used to determine whether the user oroperator should withdraw the CVC 100. If the second ratio exceeds themaximum threshold value, the CVC 100 should be withdrawn.

Alternatively, a third ratio may be calculated to determine the locationof the tip 112 of the CVC 100. The third ratio may include the ratio ofthe deflection value of the P wave detected by the distal anode/cathodepair 182 to the deflection value of the P wave detected in the SVC. Inone embodiment, the third ratio may include the ratio of the deflectionvalue of the P wave detected by the distal anode/cathode pair 182 to thedeflection value of the P wave detected by the reference anode/cathodepair 184. In embodiments that include a reference pair 184, thereference pair 184 may detect the P wave in the SVC. Because the distalanode/cathode pair 182 is inside the right atrium, the deflection valueof its P wave is greater than or equal to twice the deflection value ofthe P wave observed in the SVC. When third ratio is equal to or greaterthan two, the user or operator should withdraw the CVC 100. Under thesecircumstances, the predetermined maximum threshold value may be used todetermine whether the user or operator should withdraw the CVC 100,i.e., if the third ratio exceeds the maximum threshold value, the CVC100 should be withdrawn.

Determining when to withdraw the CVC 100 is unaffected by wide anatomicvariability between individual people because instead of usingpredetermined threshold deflection values, the first, second, and/orthird ratio of the deflection values obtained from each individual isused.

The following table summarizes the relationship between the location ofthe tip 112 of the CVC 100 and the deflection values of the P wavesdetected by the proximal and distal anode/cathode pairs 180 and 182:

Location of the distal anode/cathode pair 182 Right Right Right SVCAtrium Atrium Ventricle Location of the proximal anode/cathode pair 180Right Right SVC SVC Atrium Atrium First Ratio: Ratio of the deflection≈1 ≧2 ≈1 ≦0.5 value of the distal anode/cathode pair 182 to thedeflection value of the proximal anode/cathode pair 180 Second Ratio:Ratio of the deflection ≈1 ≈1 ≧2 ≧2   value of the P wave detected bythe proximal anode/cathode pair 180 and the deflection value of the Pwave detected in the SVC Third Ratio: Ratio of the deflection ≈1 ≧2 ≧2≈1   value of the P wave detected by the distal anode/cathode pair 182and the deflection value of the P wave detected in the SVC

Because the voltage across each of the anode/cathode pairs 180 and 182may vary depending over time, the voltage across wires 164 and 166 andwires 160 and 162 may each constitute a time-varying signal that can beanalyzed using standard signal processing methods well known in the art.In a typical patient, the maximum of voltage across the anode/cathodepairs 180 and 182 may range from about 0.2 mV to about 3 mV. The signalfrom each anode/cathode pairs 180 and 182 may be amplified and/orfiltered to improve the signal quality. A distal signal may be detectedby the distal anode/cathode pair 182 and a proximal signal may bedetected by the proximal anode/cathode pair 180. Similarly, an optionalreference signal may be detected by the reference anode/cathode pair184.

A separate ECG trace may be constructed for distal and proximal signals.In some embodiments, an ECG trace may also be constructed for thereference signal. The P wave portion of one or more of these ECG tracesmay be identified and analyzed. For example, the ECG trace of the distalsignal may be visualized by connecting wires 164 and 166 of the distalanode/cathode pair 182 to a device such as a PACERVIEW® signalconditioner designed specifically to construct and display an ECG tracefrom a time varying low voltage signal. Similarly, the ECG trace of theproximal signal may be viewed by connecting the wires 160 and 162 of theproximal anode/cathode pair 180 to a PACERVIEW® signal conditioner. TheECG trace of the reference signal may be viewed by connecting the wires167 and 168 of the proximal anode/cathode pair 184 to a PACERVIEW®signal conditioner.

In one embodiment, each of the four wires 160, 162, 164, and 166 may becoupled to a signal analysis system for analysis of the voltageinformation detected by the electrodes 150, 152, 154, and 156,respectively. In embodiments including electrodes 157 and 158, the wires167 and 168 may be coupled to the signal analysis system for analysis ofthe voltage information detected by the electrodes 157 and 158,respectively. An exemplary signal analysis system 200 for analyzing thesignals carried by wires 160, 162, 164, and 166 and alerting the user oroperator when to withdraw the tip 112 of the CVC 100 may be viewed inFIG. 4. In an alternate embodiment, the system 200 may also analyze thesignals carried by wires 167 and 168.

FIG. 5 is a block diagram of the components of the exemplary system 200.The system 200 may include a programmable central processing unit (CPU)210 which may be implemented by any known technology, such as amicroprocessor, microcontroller, application-specific integrated circuit(ASIC), digital signal processor (DSP), or the like. The CPU 200 may beintegrated into an electrical circuit, such as a conventional circuitboard, that supplies power to the CPU 210. The CPU 210 may includeinternal memory or memory 220 may be coupled thereto. The memory 220 maybe coupled to the CPU 210 by an internal bus 264.

The memory 220 may comprise random access memory (RAM) and read-onlymemory (ROM). The memory 220 contains instructions and data that controlthe operation of the CPU 210. The memory 220 may also include a basicinput/output system (BIOS), which contains the basic routines that helptransfer information between elements within the system 200. The presentinvention is not limited by the specific hardware component(s) used toimplement the CPU 210 or memory 220 components of the system 200.

Optionally, the memory 220 may include external or removable memorydevices such as floppy disk drives and optical storage devices (e.g.,CD-ROM, R/W CD-ROM, DVD, and the like). The system 200 may also includeone or more I/O interfaces (not shown) such as a serial interface (e.g.,RS-232, RS-432, and the like), an IEEE-488 interface, a universal serialbus (USB) interface, a parallel interface, and the like, for thecommunication with removable memory devices such as flash memory drives,external floppy disk drives, and the like.

The system 200 may also include a user interface 240 such as a standardcomputer monitor, LCD, colored lights 242 (see FIG. 4), PACERVIEW®signal conditioner, ECG trace display device 244 (see FIG. 4), or othervisual display including a bedside display. In one embodiment, a monitoror handheld LCD display may provide an image of a heart and a visualrepresentation of the estimated location of the tip 112 of the CVC 100.The user interface 240 may also include an audio system capable ofplaying an audible signal. In one embodiment, the user interface 240includes a red light indicating the CVC 100 should be withdrawn and agreen light indicating the CVC 100 may be advanced. In anotherembodiment, the user interface 240 includes an ECG trace display device244 capable of displaying the ECG trace of the distal and proximalsignals. In the embodiment depicted in FIG. 4, the user interface 240includes a pair of lights 242, one red and the other green, connected inseries with a ECG trace display device 244. In some embodiments, adisplay driver may provide an interface between the CPU 210 and the userinterface 240.

The user interface 240 may permit the user to enter control commandsinto the system 200. For example, the user may command the system 200 tostore information such as the deflection value of the P wave inside theSVC. The user may also use the user interface 240 to identify whichportion of the ECG trace corresponds to the P wave. The user interface240 may also allow the user or operator to enter patient informationand/or annotate the data displayed by user interface 240 and/or storedin memory 220 by the CPU 210. The user interface 240 may include astandard keyboard, mouse, track ball, buttons, touch sensitive screen,wireless user input device and the like. The user interface 240 may becoupled to the CPU 210 by an internal bus 268.

Optionally, the system 200 may also include an antenna or other signalreceiving device (not shown) such as an optical sensor for receiving acommand signal such as a radio frequency (RF) or optical signal from awireless user interface device such as a remote control. The system 200may also include software components for interpreting the command signaland executing control commands included in the command signal. Thesesoftware components may be stored in memory 220.

The system 200 includes an input signal interface 250 for receiving thedistal and proximal signals. The input signal interface 250 may also beconfigured to receive the reference signal. The input signal interface250 may include any standard electrical interface known in the art forconnecting a double dipole lead wire to a conventional circuit board aswell as any components capable of communicating a low voltage timevarying signal from a pair of wires through an internal bus 262 to theCPU 210. The input signal interface 250 may include hardware componentssuch as memory as well as standard signal processing components such asan analog to digital converter, amplifiers, filters, and the like.

The various components of the system 200 may be coupled together by theinternal buses 262, 264, and 268. Each of the internal buses 262, 264,and 268 may be constructed using a data bus, control bus, power bus, I/Obus, and the like.

The system 200 may include instructions 300 executable by the CPU 210for processing and/or analyzing the distal and/or proximal signals.These instructions may include computer readable software components ormodules stored in the memory 220. The instructions 300 may include anECG Trace Generator Module 310 that generates a traditional ECG tracefrom the distal and/or proximal signals. In some embodiments, the ECGTrace Generator Module 310 may generate a traditional ECG trace from thereference signal. As is appreciated by those of ordinary skill in theart, generating an ECG trace from an analog signal, such as the distaland proximal signals, may require digital or analog hardware components,such as an analog to digital converter, amplifiers, filters, and thelike and such embodiments are within the scope of the present invention.In one embodiment, some or all of these components may be included inthe input signal interface 250. In an alternate embodiment, some or allof these components may be implemented by software instructions includedin the ECG Trace Generator Module 310. The ECG Trace Generator 310 mayinclude any method known in the art for generating an ECG trace from atime varying voltage signal.

The instructions 300 may include a P Wave Detection Module 320 fordetecting or identifying the P wave portion of the ECG trace. The P waveportion of the ECG trace may be detected using any method known in theart. In one embodiment, the P Wave Detection Module 320 receives inputfrom the user or operator via the user interface 240. The input receivedmay identify the P wave portion of the ECG trace.

The instructions 300 may include an Interpretive Module 330 forcomparing the P wave generated for the distal, proximal, and/orreference signals. In one embodiment, the Interpretive Module 330determines the deflection value of the P wave generated for the distaland/or proximal signals. In some embodiments, the Interpretive Module330 determines the deflection value of the P wave generated for thereference signal. The Interpretive Module 330 may direct the CPU 210 tostore the deflection value of the distal, proximal, and/or referencesignals in memory 220. In particular, it may be desirable to store thedeflection value of the P wave encountered in the SVC. The InterpretiveModule 330 may receive input from the user or operator via the userinterface 240 instructing the Interpretive Module 330 to store thedeflection value.

The Interpretive Module 330 may also determine the first ratio bycalculating the ratio of the deflection value of the distal signal tothe deflection value of the proximal signal. If the first ratio isapproximately equal to or greater than the maximum threshold value, thetip 112 of the CVC 100 may be in the right atrium. The InterpretiveModule 330 may alert the user or operator that the tip 112 is in theright atrium and the CVC 100 should be withdrawn from the right atrium.On the other hand, if the first ratio is approximately equal to or lessthan the minimum threshold value, the tip 112 of the CVC 100 may be inthe right ventricle. The Interpretive Module 330 may alert the user oroperator that the tip 112 is in the right ventricle and the CVC 100should be withdrawn from therefrom.

If the first ratio is less than the maximum threshold value and greaterthan the minimum threshold value, the tip 112 may be in either the rightatrium or the SVC. When this happens, the Interpretive Module 330 maycalculate either the second ratio or third ratio. If the second or thirdratio is approximately equal to or greater than the maximum thresholdvalue, the tip may be in the right atrium and should be withdrawnthereform. The Interpretive Module 330 may alert the user or operatorthat the tip 112 is in the right atrium. If the second or third ratio isapproximately less than the maximum threshold value, the tip 112 is inthe SVC and may be advanced if the operator so chooses. The InterpretiveModule 330 may communicate to the user or operator that the tip 112 maybe advanced.

In an alternate embodiment, the second ratio may be calculated first.Whenever the second ratio is approximately equal to or greater than themaximum threshold value, the user or operator may be alerted to withdrawthe CVC 100. If the second ratio is approximately less than the maximumthreshold value, the first or third ratio may be calculated and used todetermine the position of the tip 112 of the CVC 100.

In one embodiment, the instructions in the Interpretive Module 330direct the CPU 210 to use the user interface 240 to communicate whetherthe tip 112 should be withdrawn to the user. The CPU 210 may use theuser interface 240 to communicate the tip 112 may be advanced.

While exemplary minimum and maximum threshold values have been providedas a general guideline, those of ordinary skill in the art appreciatethat these values may benefit from adjustment as additional anatomic orelectrophysiologic data is acquired and such modified values are withinthe scope of the present invention. Because the Interpretive Module 330may interpret the P wave to obtain the deflection values of the distaland proximal signals, compare the deflection values and provide theoperator with immediate real-time feedback, the operator need notinterpret the actual ECG waveforms.

The foregoing described embodiments depict different componentscontained within, or connected with, different other components. It isto be understood that such depicted architectures are merely exemplary,and that in fact many other architectures can be implemented whichachieve the same functionality. In a conceptual sense, any arrangementof components to achieve the same functionality is effectively“associated” such that the desired functionality is achieved. Hence, anytwo components herein combined to achieve a particular functionality canbe seen as “associated with” each other such that the desiredfunctionality is achieved, irrespective of architectures or intermedialcomponents. Likewise, any two components so associated can also beviewed as being “operably connected”, or “operably coupled”, to eachother to achieve the desired functionality.

While particular embodiments of the present invention have been shownand described, it will be obvious to those skilled in the art that,based upon the teachings herein, changes and modifications may be madewithout departing from this invention and its broader aspects and,therefore, the appended claims are to encompass within their scope allsuch changes and modifications as are within the true spirit and scopeof this invention. Furthermore, it is to be understood that theinvention is solely defined by the appended claims. It will beunderstood by those within the art that, in general, terms used herein,and especially in the appended claims (e.g., bodies of the appendedclaims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to inventions containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations. In addition, evenif a specific number of an introduced claim recitation is explicitlyrecited, those skilled in the art will recognize that such recitationshould typically be interpreted to mean at least the recited number(e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations).

Accordingly, the invention is not limited except as by the appendedclaims.

What is claimed is:
 1. A method of locating a tip of a central venous catheter based on a reference P wave detected by a reference pair of electrodes, a first P wave detected by a first pair of electrodes disposed near the tip of the central venous catheter, and a second P wave detected by a second pair of electrodes disposed on the central venous catheter and spaced proximally from the first pair, the method comprising: determining a first deflection value as a function of the first P wave; determining a second deflection value as a function of the second P wave; calculating a reference deflection value as a function of the reference P wave; comparing the first deflection value to the second deflection value; comparing the reference P wave with at least one of the first and second P waves; and determining a location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves.
 2. The method according to claim 1, wherein comparing the first deflection value to the second deflection value comprises calculating a first ratio of the first deflection value to the second deflection value, and wherein determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the first ratio to a predetermined maximum threshold.
 3. The method according to claim 1, wherein comparing the first deflection value to the second deflection value comprises calculating a first ratio of the first deflection value to the second deflection value, and wherein determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the first ratio to a predetermined minimum threshold.
 4. The method according to claim 1, wherein comparing the reference P wave with at least one of the first and second P waves comprises calculating a second ratio of one of the first and second deflection values to the reference deflection value, and wherein determining the location of the tip of the central venous catheter based on the comparison of the first and second deflection values and the comparison of the reference P wave with at least one of the first and second P waves comprise comparing the second ratio to a predetermined maximum threshold.
 5. The method according to claim 1, wherein the first, second, and reference P waves each comprise a series of discrete numerical values, and wherein calculating the first, second and reference deflection values as a function of the first, second, and reference P waves comprise: determining a maximum value within the series of discrete numerical values of the P wave; determining a minimum value within the series of discrete numerical values of the P wave; determining a polarity of the maximum value and a polarity of the minimum value; comparing the polarity of the maximum value to the polarity of the minimum value; determining a larger of an absolute value of the maximum value and an absolute value of the minimum value; and totaling the absolute values of the maximum and minimum values.
 6. The method according to claim 1, wherein comparing the first deflection value to the second deflection value comprises calculating a first ratio of the first deflection value to the second deflection value, and wherein comparing the reference P wave with at least one of the first and second P waves comprises calculating a second ratio of one of the first and second deflection values to the reference deflection value, further comprising: without advancing or withdrawing the tip of the central venous catheter, either determining that the tip of the central venous catheter is located in a desired location when the first ratio and the second ratio are both approximately one, or that the tip of the central venous catheter has been inserted too far when the second ratio is greater than a maximum predefined threshold value, when the first ratio is greater than the maximum predefined threshold value, or when the first ratio is less than a minimum predefined threshold value. 